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Reporter: Ritu Saxena, Ph.D.

Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center Initiative.

Researchers at the MD Anderson Cancer center initiated a personalized medicine program by moving to phase I early clinical trials. The tumors were analyzed for molecular aberrations and matched with suitable targeted agents. Treatment assignment was not randomized. With a study involving 144 patients with advanced cancer stages, the authors found that the patients that underwent matched therapy based on their single aberration type, showed better results in terms of survival as compared to similar single aberration carrying patients who underwent systemic therapy (median, 13.4 vs. 9.0 months; p = 0.017).

The findings have been published a few days ago in the November 15th issue of Clinical Cancer Research Journal.

Abstract: Tsimberidou AM et al, Personalized medicine in a phase I clinical trials program: the MD anderson cancer center initiative. Clin Cancer Res. 2012 Nov 15;18(22):6373-83.

Authors’ Affiliations: Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program; and Departments of Hematopathology and Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.

PURPOSE:

We initiated a personalized medicine program in the context of early clinical trials, using targeted agents matched with tumor molecular aberrations. Herein, we report our observations. Patient and Methods: Patients with advanced cancer were treated in the Clinical Center for Targeted Therapy. Molecular analysis was conducted in the MD Anderson Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Patients whose tumors had an aberration were treated with matched targeted therapy, when available. Treatment assignment was not randomized. The clinical outcomes of patients with molecular aberrations treated with matched targeted therapy were compared with those of consecutive patients who were not treated with matched targeted therapy.

RESULTS:

Of 1,144 patients analyzed, 460 (40.2%) had 1 or more aberration. In patients with 1 molecular aberration, matched therapy (n = 175) compared with treatment without matching (n = 116) was associated with a higher overall response rate (27% vs. 5%; P < 0.0001), longer time-to-treatment failure (TTF; median, 5.2 vs. 2.2 months; P < 0.0001), and longer survival (median, 13.4 vs. 9.0 months; P = 0.017). Matched targeted therapy was associated with longer TTF compared with their prior systemic therapy in patients with 1 mutation (5.2 vs. 3.1 months, respectively; P < 0.0001). In multivariate analysis in patients with 1 molecular aberration, matched therapy was an independent factor predicting response (P = 0.001) and TTF (P = 0.0001).

CONCLUSION:

Keeping in mind that the study was not randomized and patients had diverse tumor types and a median of 5 prior therapies, our results suggest that identifying specific molecular abnormalities and choosing therapy based on these abnormalities is relevant in phase I clinical trials.

Sources:

Research article by Tsimberidou AM et al. Clin Cancer Res. 2012 Nov 15;18(22):6373-83.

News brief by Virginia Postrel, a Bloomberg View Columnist, Cancer Breakthroughs Meet Market Realities, November, 2012.

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